U.S. patent number 4,808,155 [Application Number 07/097,378] was granted by the patent office on 1989-02-28 for simple double lumen catheter.
Invention is credited to Sakharam D. Mahurkar.
United States Patent |
4,808,155 |
Mahurkar |
February 28, 1989 |
**Please see images for:
( Certificate of Correction ) ( Reexamination Certificate
) ** |
Simple double lumen catheter
Abstract
A double lumen catheter having an elongated tube with a proximal
cylindrical portion enclosing first and second lumens separated by
an internal divider, the proximal end of the elongated tube
connecting to two separate connecting tubes communicating with the
respective first and second lumens for the injection and removal of
blood, the first lumen extending from the proximal end of the
elongated tube to a first opening at the distal end of the
elongated tube, and the second lumen extending from the proximal
end of the elongated tube to a second opening spaced a sufficient
distance away from the first opening, in the longitudinal
direction, to prevent mixing of the returned blood with the blood
taken in, the tube having a non-conical and non-tapered distal end
portion having a reduced cross-sectional area and extending from
said second opening and terminating in a blunt end to prevent the
end of the catheter from traumatizing or becoming caught in the
walls of a blood vessel into which the catheter is inserted.
Inventors: |
Mahurkar; Sakharam D. (Chicago,
IL) |
Family
ID: |
26793183 |
Appl.
No.: |
07/097,378 |
Filed: |
September 16, 1987 |
Related U.S. Patent Documents
|
|
|
|
|
|
|
Application
Number |
Filing Date |
Patent Number |
Issue Date |
|
|
833978 |
Feb 27, 1986 |
|
|
|
|
544883 |
Oct 24, 1983 |
|
|
|
|
Current U.S.
Class: |
604/43; 604/523;
604/6.16 |
Current CPC
Class: |
A61M
25/0068 (20130101); A61M 2025/0031 (20130101); A61M
2025/0037 (20130101) |
Current International
Class: |
A61M
25/00 (20060101); A61M 025/00 () |
Field of
Search: |
;604/4,5,43-45,280-284 |
References Cited
[Referenced By]
U.S. Patent Documents
Foreign Patent Documents
|
|
|
|
|
|
|
834211 |
|
Feb 1976 |
|
BE |
|
1092927 |
|
Jan 1981 |
|
CA |
|
50089 |
|
Aug 1982 |
|
CA |
|
1150122 |
|
Jul 1983 |
|
CA |
|
1167727 |
|
May 1984 |
|
CA |
|
36642 |
|
Sep 1981 |
|
EP |
|
0079719 |
|
Nov 1982 |
|
EP |
|
935625 |
|
Nov 1955 |
|
DE |
|
2259865 |
|
Jun 1974 |
|
DE |
|
19346 |
|
Jun 1982 |
|
DE |
|
592193 |
|
Apr 1925 |
|
FR |
|
1285953 |
|
Jul 1962 |
|
FR |
|
1508959 |
|
Jan 1968 |
|
FR |
|
2285148 |
|
Apr 1976 |
|
FR |
|
2297640 |
|
Aug 1976 |
|
FR |
|
821344 |
|
Apr 1982 |
|
FR |
|
55-88771 |
|
Jul 1980 |
|
JP |
|
1017315 |
|
May 1983 |
|
SU |
|
688450 |
|
Mar 1952 |
|
GB |
|
1419702 |
|
Dec 1975 |
|
GB |
|
1006219 |
|
Mar 1983 |
|
GB |
|
Other References
McIntosh et al., "Double Lumen Catheter," J.A.M.A., Feb. 21, 1959,
pp. 137/835-138/836. .
Dorland's Illustrated Medical Dictionary, 25th Ed., W. B. Saunders
Co., Phila., 1974, p. 274. .
Brenner & Rector, The Kidney, vol. III, W. B. Saunders Co.,
Phila., 1976, p. 164. .
ASAIO Abstracts, vol. 5, 22nd Annual Meeting, San Francisco,
California, Apr. 1-3, 1976, p. 52. .
Tohuko, J., "Single Two-Lumen Cannula Dialysis", Aug. 1974. .
Tsuchida et al., "Single Two-Lumen Cannula Dialysis", Toboku
Journal Exp. Med., 1974, pp. 114, 159-101. .
Tsuchida et al., "Design of a Two-Lumen-Piercing Needle That is
Capable of Carrying Out Dialysis by Single Puncture", Journal of
the Urological Society of Japan, vol. 65 (12), 1974, pp. 805-807.
.
Kaplan et al., "A Co-Axial Dual Flow Catheter/Canula for Single
Puncture Dialysis", Dialysis & Transplantation, Dec./Jan. 1977,
pp. 38-40, 42, 84..
|
Primary Examiner: Truluck; Dalton L.
Attorney, Agent or Firm: Rudisill; Stephen G.
Parent Case Text
RELATED APPLICATIONS
This is a continuation of co-pending application Ser. No. 833,978,
filed on 2/27/86 which is a continuation of Ser. No. 544,883, filed
10/24/83, both now abandoned.
Claims
What is claimed is:
1. A double lumen catheter having an elongated tube with a proximal
cylindrical portion enclosing first and second lumens separated by
an internal divider, the proximal end of said elongated tube
connecting to two separate connecting tubes communicating with the
respective first and second lumens, the first lumen extending from
the proximal end of said elongated tube to a first opening at the
distal end of said elongated tube, and the second lumen extending
from the proximal end of said elongated tube to a second opening
spaced in the longitudinal direction away from said first opening,
said tube having a non-conical and non-tapered distal end portion
having a cross-sectional area smaller than the cross-sectional area
of said proximal cylindrical portion, and said distal end portion
extending from said second opening and terminating in a blunt
distal end to prevent the distal end of the catheter from
traumatizing or becoming caught in the walls of a vessel into which
the catheter is inserted.
2. The double lumen catheter as claimed in claim 1, wherein said
divider is planar in said cylindrical portion and extends to said
blunt distal end to comprise approximately one-half of the
peripheral wall of said distal end portion between said first and
second openings.
3. The double lumen catheter as claimed in claim 2, wherein said
second opening is defined by a bevel arising at its proximal end on
the outer periphery of said cylindrical portion opposite the second
lumen and terminating at its distal end on the planar divider.
4. The double lumen catheter as claimed in claim 1, wherein the
lumens are "D" shaped in cross-section.
5. The double lumen catheter as claimed in claim 1, wherein
said divider in said cylindrical portion is planar, and each of
said lumens is "D" shaped in cross-section along its entire
length.
6. The double lumen catheter as claimed in claim 5 wherein said
second opening is defined by a bevel arising at its distal end on
the outer periphery of said cylindrical portion, and terminating
towards the planal divider.
7. A double lumen catheter comprising an elongated unitary tube
having a proximal cylindrical portion including a longitudinal
septum of one-piece construction with said tube, said septum being
planar in said proximal cylindrical portion and dividing the
interior of said proximal cylindrical portion into first and second
lumens, the proximal end of said tube connecting to two separate
tubes communicating with the respective first and second lumens for
the injection and removal of fluid, the first lumen extending from
the proximal end of said tube to a first opening at the distal end
of said tube and the second lumen extending from the proximal end
of said tube to a second opening at the distal end of said proximal
cylindrical portion, said second opening being spaced in the
longitudinal direction away from said first opening, said tube
having a distal end portion of substantially uniform cross-section
and a cross-sectional area smaller than the cross-sectional area of
said proximal cylindrical portion, said distal end portion
extending from said second opening and terminating in a blunt end
to prevent the end of the catheter from traumatizing or becoming
caught in the walls of a vessel into which the catheter is
inserted, wherein said septum extends to said blunt distal end to
comprise a portion of the peripheral wall of said distal end
portion between said first and second openings.
8. The double lumen catheter as claimed in claim 7, wherein the
first and second lumens and said distal end portion are each "D"
shaped in cross section.
9. A double lumen catheter as claimed in claim 7, wherein said
first opening at the distal end of said tube is eccentric with
respect to the axis of the cylindrical portion of said tube.
10. A double lumen catheter comprising an elongated tube having a
proximal cylindrical portion including a planar axial divider
bisecting said cylindrical portion of the tube into first and
second lumens, the proximal end of said tube connecting two
separate tubes communicating with the respective first and second
lumens for the injection and removal of fluid, the first lumen
extending from the proximal end of said tube to a first opening at
the distal end of said tube, the second lumen extending from the
proximal end of said tube to a second opening at the distal end of
said proximal cylindrical portion, said second opening being spaced
in the longitudinal direction away from said first opening, the
distal end of said tube having a blunt end to prevent the end of
the catheter from traumatizing or becoming caught in the walls of a
vessel into which the catheter is inserted, wherein said tube has a
distal end portion extending from said second opening and
terminating at said distal tip, and said planar axial divider
extends to form a flat peripheral wall of said distal end portion,
said flat peripheral wall exending to said blunt distal tip.
11. The double lumen catheter as claimed in claim 10, wherein the
first opening in the distal end of said tube is eccentric with
respect to the axis of the proximal cylindrical portion of the
tube.
12. The double lumen catheter as claimed in claim 10, wherein the
first and second lumens and said distal end portion each have a
uniform "D" shaped cross section.
Description
BACKGROUND OF THE INVENTION
1. Field of Invention
The present invention relates to surgical instruments for
withdrawing fluids from or introducing fluids into a cavity of the
body.
2. Description of the Related Art
As is well known, a catheter is a tubular, flexible, surgical
instrument for withdrawing fluids from (or introducing fluids into)
a cavity of the body. A double-current catheter is a catheter
having two channels; one for injection and one for removal of
fluid. Dorlan's Illustrated Medical Dictionary, Twenty
Fifth-Edition (W. B. Saunders, Philadelphia 1974), p. 274. As is
well known, a double-current catheter is used for removing blood
from a fistula or vein for processing in a dialysis machine and
returning the processed blood back to the fistula or vein. A
double-current catheter suitable for this purpose is disclosed in
Mahurkar, U.S. Pat. No. 4,134,402 issued Jan. 16. 1979. Mahurkar
U.S. Pat. No. 4,134,402 discloses a double lumen continuous flow
hemodialysis needle and cannula having contiguous lumens of
different lengths formed by dividing a unitary straight tube, the
shorter lumen acting as a blood intake lumen and the longer acting
as a blood return lumen. A sharp penetrating bevel is provided on
the distal tip for percutaneous entry into a fistula. Semi-circular
lumens provide a minimal resistance to blood flow resulting in a
smaller but highly efficient catheter in comparison to a coaxial
double-current catheter. Hemodialysis requires, for example, a
blood flow rate of about 200ml/min or more and flow resistance less
than about 100 mm of mercury.
There are numerous other United States Patents disclosing
double-current catheters for hemodialysis and evidencing a
long-felt need for a small, functionally efficient catheter having
a minimum of insertion trauma and potential for clotting.
McLaughlin, U.S. Pat. No. 4,096,860 issued June 27, 1978 discloses
a coaxial hemodialysis catheter said to allow a step enlargement of
the opening of a blood vessel to avoid tearing and rupture of the
side walls. A simultaneous flow device incorporates a hub with an
extension conduit and a valve therein for receipt of a needle
therethrough. The extension conduit is of sufficient size to allow
the passage of the needle therethrough adjacent the interior side
walls thereof with an attendant extension thereof from its opening.
The needle with the extension conduit is adapted for combined
insertion within a blood vessel, after which it can be withdrawn
while the valve prevents the backflow of blood through the axial
passage of the hub. A coaxial flow device can then be inserted
within the hub conduit.
Sorensen et al., U.S. Pat. No. 4,099,528 issued July 11, 1978
discloses a coaxial double lumen cannula mounted upon a hub and
having a central stylet needle for penetrating a patient's vein and
which is retractable after penetration.
Grimsrud, U.S. Pat. No. 4,203,436 issued May 20, 1980 discloses a
hollow hypodermic needle with a divider for providing a first
channel for removal of blood for treatment from a punctured blood
vessel and a second channel for returning the treated blood to the
blood vessel.
Uthmann, U.S. Pat. No. 4,385,631 issued May 31, 1983 discloses a
hemodialysis catheter for puncturing blood vessels which includes a
section insertable through a puncture opening into a blood vessel
and a hose line following thereafter. This catheter has two
circular lumens arranged side by side. One of the circular lumens
has a sloping bevel while the other circular lumen passes slidably
through a sheath integral with the first lumen. This device
requires a large puncture opening and produces an inefficient
relationship of flow rate to puncture area.
Jacobson et al., U.S. Pat. No. 4,180,068 issued Dec. 25, 1979
discloses a double-current hemodialysis catheter comprising a
primary tube and an internal divider which also functions as a
trocar and valve. The primary tube has a side opening for receiving
blood and a central opening at the distal end of the primary tube.
The internal divider includes a cutting end which protrudes from
the distal opening when the divider is longitudinally moved to an
insert position. In the insert postion, blood flow is blocked.
Mahurkar, U.S. Pat. No. Des. 272,651 issued Feb. 14, 1984 discloses
a double lumen catheter having an outlet lumen which has an opening
at the tip of the catheter and a shorter inlet lumen which
terminates in a bevel substantially displaced from the tip.
Uldall U.S. Pat. No. 272,651 issued Feb. 14, 1984 discloses a
double lumen catheter having an outlet lumen which has an opening
at the tip of the catheter and a shorter inlet lumen which
terminates in a bevel substantially displaced from the tip.
Uldall U.S. Pat. No. 4,493,696 issued Jan. 15, 1985 described a
coaxial double lumen catheter in which the outer lumen is
constricted at its distal end, and the tip of the inner lumen rests
against the beginning of this constriction. Blood is withdrawn for
processing through the outer lumen via multiple openings in the
outer wall; the processed blood is returned through the inner
lumen.
SUMMARY OF THE INVENTION
The primary object of the invention is to provide a simple and
efficient double lumen catheter of small size which will not
traumatize or become caught in the walls of a blood vessel into
which the catheter is inserted, and yet is relatively easy to
insert into the blood vessel.
A further object of this invention is to provide a double lumen
catheter which is easy and inexpensive to manufacture.
Other objects and advantages of the invention will become apparent
from the following detailed description and the accompanying
drawings.
BRIEF DESCRIPTION OF DRAWINGS
In the drawings:
FIG. 1 is a front and rear elevational view of a double lumen
catheter embodying my invention;
FIG. 2 is a right side elevational view of the catheter illustrated
in FIG. 1;
FIG. 3 is a left side elevational view of catheter illustrated in
FIG. 1;
FIG. 4 is a section taken generally along line 4--4 thereof in FIG.
2;
FIG. 5 is a section taken generally along line 5--5 in FIG. 1;
and
FIG. 6 is a top view of the catheter illustrated in FIG. 1.
While the invention will be described in connection with a certain
preferrred embodiment, it will be understood that it is not
intended to limit the invention to that particular embodiment. On
the contrary, it is intended to cover all alternatives,
modifications, and equivalents as may be included within the spirit
and scope of the invention as defined by the appended claims.
DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS
Turning now to the drawings, FIGS. 1, 2, 3 and 6 show various
external views of a simple double lumen catheter, generally
designated 10, in accordance with the present invention. As is
conventional for a catheter, the double lumen catheter 10 has an
elongated unitary hollow tube 11 which is inserted into a body
cavity such as a vein. The major portion of the tube 11 is circular
in cross section, as shown in FIG. 5, and has an internal planar
axial divider or septum 12 defining a return lumen 13 and an inlet
lumen 14 within the interior of the hollow tube 11. This divider 12
is preferably of unitary or one-piece construction with the tube
11, bisecting the tube into the two lumens 13 and 14. The
transverse cross-sections of the lumens 13 and 14 are semicircular
or "D" shaped (see FIG. 5) which minimizes resistance to fluid
flow.
As is conventional for this type of dual lumen construction, the
divider 12 extends axially along the interior of the tube 11 from a
branching connector 15. The branching connector 15 connects the
proximal ends of the return lumen 13 and the inlet lumen 14 to
respective fluid return and inlet lines 16 and 17 which are, for
example, respective venous and arterial lines of a dialysis or
plasmapheresis circuit. The preferred direction of fluid
circulation is indicated by dashed arrows in FIG. 1.
The hollow tube 11 includes openings or apertures at the distal end
portions of the lumens 13 and 14 to permit the flow of the fluid
between a body cavity (not shown) and the lumens. The return lumen
13 extends along the entire length of the tube 11 to an aperture or
opening 18 at the distal end of the tube 11 as is more clearly
shown in FIG. 4. The inlet lumen 14 is shorter than the return
lumen 13 and terminates at an aperture or opening 19 that is
substantially displaced from the return aperture 18 at the distal
end of the tube 11. Both lumens 13 and 14 are straight along their
entire lengths, and thus their respective openings 18 and 19 are
aligned with the axes of the respective lumens, but eccentric with
respect to the central axis of the tube 11. The longitudinal
spacing of the distal openings 18 and 19 prevents mixing of the
returned blood with the blood taken in.
In accordance with the invention, the tube 11 terminates with a
blunt distal end 20 which is normal to the axis of the catheter 10.
It does not have the conical tip or taper that is characteristic of
other catheters. The absence of the conical tip avoids trauma and
migration of the catheter into the tributaries of the veins, e.g.,
the blunt end prevents the end of the catheter from traumatizing or
becoming caught in the walls of a blood vessel into which the
catheter is inserted. The intake lumen 14, on the other hand,
preferably forms a bevel 21 at its distal end. Beyond the bevel 21
the divider 12 and half of the hollow tube 11 continue to the blunt
distal end portion 20 of the return lumen 13.
The dual lumen tube 11 can be formed by extrusion or molding of a
polymeric material. After the tube has been cut to the desired
length, the bevel 21 is formed by simply cutting the desired angle
of bevel through the wall of that half of the tube that forms the
lumen 14 (see FIGS. 3 and 4), and then continuing the cut
longitudinally along one side of the divider 12 to the distal end
of the tube. After this cut portion of the tube has been removed,
the divider 12 merges with only about one-half of the cylindrical
portion of the tube between the openings 18 and 19, as can be seen
in FIGS. 3, 4, and 6.
For use in hemodialysis, the double lumen catheter 10 is introduced
in the direction of blood flow in a large vein, surgically under
direct vision or over a Seldinger's guide wire through a sheath as
is conventional. The inlet opening 19 on the blood inlet lumen 14
draws the blood for processing and the processed blood is returned
through the return lumen 13 and out through the hole to return the
blood upstream into circulation.
* * * * *